Quality Engineer, Product Quality Assurance

Date: Oct 12, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4879

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Supports the Product Quality Assurance team analyzing post-market data and potential product quality issues for commercialized devices.  Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross-functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485 and 14971. 

Principal Responsibilities

•    Create, investigate and/or manage nonconformances, as well as associated ship holds and product disposition 
•    Investigate, compile and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted. 
•    Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Sterilization, and Regulatory to investigate and document quality issues.
•    Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership. Utilize basic statistical techniques to identify rates, changes in trends or estimated occurrences based on bench and field data.
•    Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues 
•    Assist during regulatory inspections and/or audits and present as required
•    Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance.  
•    Communicate and escalate Quality issues appropriately to QA Manager and address other items as assigned by Manager 
 

Education / Experience Requirements

•    BS Degree Engineering (or related technical field)
•    3-5 years related (medical device preferred) experience 
 

Specialized Skills / Other Requirements

•    Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
•    Experience with Corrective Action, Manufacturing and Design Control concepts desired
•    Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)
•    Positive attitude and ability to operate and communicate effectively with multiple teams & leadership
•    Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change
 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh